Head and Neck CancerNCT07910149
Airway Ultrasound in Oncologic Maxillofacial Patients
An observational study of Head and Neck Cancer, run by University Hospital Dubrava at 2 sites in Croatia.
Trial summary
This prospective observational cohort study will evaluate ultrasound-based airway measurements in adult patients with oncologic maxillofacial disease undergoing surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- How many people
- 30 participants
- Where
- 2 sitesCroatia
- Study dates
- Sep 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with oncologic disease of the maxillofacial or head and neck region, scheduled for elective surgery under general anesthesia with planned airway management requiring tracheal intubation.
Who may be able to join
- Adults aged 18 years or older.
- Patients with oncologic disease of the maxillofacial or head and neck region. 3. Patients scheduled for elective surgery under general anesthesia with planned airway management requiring tracheal intubation.
- 4. Availability of a preoperative CT examination suitable for the predefined airway measurements.
- 5. Written informed consent to participate.
Who cannot join
- Age below 18 years.
- Emergency surgery.
- Inability to obtain interpretable ultrasound measurements.
- CT images unsuitable for the predefined anatomical measurements.
- Refusal to participate or inability to provide informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia2 sites, 2 recruiting
- Recruiting
Universitiy Hospital Dubrava
Zagreb, City of Zagreb, 10000
Marcela Čučković, 38512902444, mmarcec@kbd.hr
- Recruiting
University Hospital Dubrava
Zagreb, City of Zagreb, 10000
Marcela Čučković, MD, 38512902444, mmarcec@kbd.hr
Marcela Čučković, MD
About this study
Official title: Ultrasound Assessment of the Airway in Oncologic Maxillofacial Patients: Comparison With Computed Tomography and Association With Difficult Airway Management
This prospective observational cohort study will evaluate ultrasound-based airway measurements in adult patients with oncologic maxillofacial disease undergoing surgery under general anesthesia. The distance from the skin to the epiglottis (DSE) and the distance from the skin to the hyoid bone (DSHB) will be measured using preoperative airway ultrasonography and compared with corresponding measurements obtained from clinically indicated preoperative computed tomography (CT) images. The study will also investigate associations between ultrasound measurements and clinical characteristics related to airway management, including difficult tracheal intubation, difficult mask ventilation, trismus, tumor location, and previous radiotherapy
Read the detailed description
Adult patients with oncologic maxillofacial disease scheduled for elective surgery under general anesthesia will be prospectively enrolled.
Before induction of anesthesia, an ultrasound examination of the anterior neck will be performed by a trained anesthesiologist using a predefined measurement protocol. The distance from the skin to the epiglottis (DSE) and the distance from the skin to the hyoid bone (DSHB) will be recorded. Patient positioning and the ultrasound measurement technique will be standardized according to the study protocol.
Corresponding measurements will be obtained from preoperatively available CT examinations by a radiologist using predefined anatomical landmarks and measurement planes. No CT examination will be performed solely for research purposes.
The primary analysis will assess the agreement between ultrasound-based and CT-based DSE measurements. Agreement between ultrasound-based and CT-based DSHB measurements will be assessed as a secondary outcome.
Clinical airway characteristics and perioperative airway management data will be recorded. Difficult tracheal intubation will be evaluated using the Intubation Difficulty Scale (IDS), with an IDS score greater than 5 defining difficult intubation when the scale can be validly applied. Difficult mask ventilation will be classified according to the Han classification.
Patients for whom awake fiberoptic intubation is planned before induction because of a recognized difficult airway, including severe trismus or tumor-related anatomical distortion, will not undergo an attempt at conventional intubation solely for research purposes. These patients will be documented separately as having a pre-recognized difficult airway. IDS-based analyses will be restricted to patients in whom the scale can appropriately be assessed.
The study will not assign treatment or alter the planned airway management. All clinical decisions will remain the responsibility of the treating anesthesiologist.
- Conditions
- Head and Neck Cancer
- Keywords
- airway ultrasonography, difficult ventilation, difficult intubation, difficult airway management, head and neck cancer, distance from skin to epiglottis, distance from skin to hyoid bone, computed tomography
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with oncologic maxillofacial disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between ultrasound and CT measurements of DSE
Agreement between ultrasound measured and CT measured distance from skin to epiglottis
Measured: Perioperative
Secondary outcomes (7)
Agreement between ultrasound-measured and CT-measured distance from the skin to the hyoid bone (DSHB)
Measured: Perioperative
Association between ultrasound-measured DSE and difficult tracheal intubation, defined as an Intubation Difficulty Scale (IDS) score greater than 5
Measured: Perioperative
Association between ultrasound-measured DSHB and difficult tracheal intubation, defined as an Intubation Difficulty Scale (IDS) score greater than 5
Measured: Perioperative
Association between ultrasound-measured DSE and DSHB and difficult mask ventilation classified according to the Han classification
Measured: Perioperative
Association between ultrasound-measured DSE and DSHB and preoperative clinical predictors of difficult intubation (maximal interincisal distance, Mallampati score, thyromental distance, neck circumference, neck mobility)
Measured: Perioperative
Reproducibility of repeated ultrasound measurements of DSE and DSHB in the predefined subset of the first 10 participants
Measured: Perioperative
Association between ultrasound-measured DSE and DSHB and tumor location and previous radiotherapy.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcela Čučković, University Hospital Dubrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910149
- Sponsor's protocol ID
- 2026/0903-7
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant-level data will not be made publicly available. Study results may be disseminated in scientific publications using aggregated data. Data will be handled in accordance with applicable data protection requirements and the approved study protocol.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of the Airway in Oncologic Maxillofacial Patients: Comparison With Computed Tomography and Association With Difficult Airway Management
- ClinicalTrials.gov ID
- NCT07910149
- Acronym / sponsor ID
- 2026/0903-7
- Conditions
- Head and Neck Cancer
- Keywords
- airway ultrasonography, difficult ventilation, difficult intubation, difficult airway management, head and neck cancer, distance from skin to epiglottis, distance from skin to hyoid bone, computed tomography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational cohort study will evaluate ultrasound-based airway measurements in adult patients with oncologic maxillofacial disease undergoing surgery under general anesthesia. The distance from the skin to the epiglottis (DSE) and the distance from the skin to the hyoid bone (DSHB) will be measured using preoperative airway ultrasonography and compared with corresponding measurements obtained from clinically indicated preoperative computed tomography (CT) images. The study will also investigate associations between ultrasound measurements and clinical characteristics related to airway management, including difficult tracheal intubation, difficult mask ventilation, trismus, tumor location, and previous radiotherapy
Detailed description
Adult patients with oncologic maxillofacial disease scheduled for elective surgery under general anesthesia will be prospectively enrolled.
Before induction of anesthesia, an ultrasound examination of the anterior neck will be performed by a trained anesthesiologist using a predefined measurement protocol. The distance from the skin to the epiglottis (DSE) and the distance from the skin to the hyoid bone (DSHB) will be recorded. Patient positioning and the ultrasound measurement technique will be standardized according to the study protocol.
Corresponding measurements will be obtained from preoperatively available CT examinations by a radiologist using predefined anatomical landmarks and measurement planes. No CT examination will be performed solely for research purposes.
The primary analysis will assess the agreement between ultrasound-based and CT-based DSE measurements. Agreement between ultrasound-based and CT-based DSHB measurements will be assessed as a secondary outcome.
Clinical airway characteristics and perioperative airway management data will be recorded. Difficult tracheal intubation will be evaluated using the Intubation Difficulty Scale (IDS), with an IDS score greater than 5 defining difficult intubation when the scale can be validly applied. Difficult mask ventilation will be classified according to the Han classification.
Patients for whom awake fiberoptic intubation is planned before induction because of a recognized difficult airway, including severe trismus or tumor-related anatomical distortion, will not undergo an attempt at conventional intubation solely for research purposes. These patients will be documented separately as having a pre-recognized difficult airway. IDS-based analyses will be restricted to patients in whom the scale can appropriately be assessed.
The study will not assign treatment or alter the planned airway management. All clinical decisions will remain the responsibility of the treating anesthesiologist.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with oncologic maxillofacial disease | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with oncologic disease of the maxillofacial or head and neck region, scheduled for elective surgery under general anesthesia with planned airway management requiring tracheal intubation.
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Patients with oncologic disease of the maxillofacial or head and neck region. 3. Patients scheduled for elective surgery under general anesthesia with planned airway management requiring tracheal intubation.
- 4. Availability of a preoperative CT examination suitable for the predefined airway measurements.
- 5. Written informed consent to participate.
Key exclusion criteria (5 listed)
- Age below 18 years.
- Emergency surgery.
- Inability to obtain interpretable ultrasound measurements.
- CT images unsuitable for the predefined anatomical measurements.
- Refusal to participate or inability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement between ultrasound and CT measurements of DSE
Time frame: Perioperative
Agreement between ultrasound measured and CT measured distance from skin to epiglottis
7 secondary outcomes
Agreement between ultrasound-measured and CT-measured distance from the skin to the hyoid bone (DSHB)
Time frame: Perioperative
Association between ultrasound-measured DSE and difficult tracheal intubation, defined as an Intubation Difficulty Scale (IDS) score greater than 5
Time frame: Perioperative
Association between ultrasound-measured DSHB and difficult tracheal intubation, defined as an Intubation Difficulty Scale (IDS) score greater than 5
Time frame: Perioperative
Association between ultrasound-measured DSE and DSHB and difficult mask ventilation classified according to the Han classification
Time frame: Perioperative
Association between ultrasound-measured DSE and DSHB and preoperative clinical predictors of difficult intubation (maximal interincisal distance, Mallampati score, thyromental distance, neck circumference, neck mobility)
Time frame: Perioperative
Reproducibility of repeated ultrasound measurements of DSE and DSHB in the predefined subset of the first 10 participants
Time frame: Perioperative
Association between ultrasound-measured DSE and DSHB and tumor location and previous radiotherapy.
Time frame: Perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant-level data will not be made publicly available. Study results may be disseminated in scientific publications using aggregated data. Data will be handled in accordance with applicable data protection requirements and the approved study protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by University Hospital Dubrava at 2 sites in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcela Čučković (38512902444, mmarcec@kbd.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between ultrasound and CT measurements of DSE (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.